Recent Updates
Recently added Catalysts

Hydromorphone

Phase 1

Pain | Small molecule | Pain |Masimo Corporation|Last Updated: Jan 3, 2019

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment45
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01866254Use of Intrathecal Hydromorphone in Elective Cesarean DeliveriesEARLY_PHASE1 COMPLETED 45May 1, 2013Oct 22, 2018Jan 3, 20191 United States
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Change in Pain Scores
from Baseline to 24 Hours

Pain scores to be measured using the verbal response scale (VRS). The VRS pain score is measured on a scale of 0-10 with 0 representing absolutely no pain and 10 representing worst pain imaginable

Secondary Endpoints
Number of Participants with Adverse Events (AEs)
up to 24 Hours
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
HydromorphoneEXPERIMENTAL100 mg, intrathecal administration
MorphineACTIVE_COMPARATOR200 mg, intrathecal administration
Interventions
NameTypeDescription
HydromorphoneDRUGInjection of 100 mcg hydromorphone into the intrathecal space
MorphineDRUGInjection of 200 mcg of intrathecal morphine
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — 40 Years
SexFEMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Scheduled for elective Cesarean sections under spinal anesthesia or combined spinal anesthesia * ASA status of I-III * BMI \< 40 * Able to understand and sign informed consent Exclusion Criteria: * Severe pre-eclampsia * Conversion to general anesthetic * History of chronic ...

Countries:United States
Unlock Eligibility Criteria